Merit Maestro® 00884450358139Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
All models of Merit Maestro (27)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450358139), received between Oct 20, 2021 and Oct 20, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Nov 6, 2023Class IIOpen, Classified
The sterility of microcatheter and infusion system devices cannot be guaranteed.
Z-0627-2024 · Root cause: Package design/selection · Recall details · FDA record ↗
Most reported problems
Device problems
- Fracture1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 20, 2021Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT DURING A PERCUTANEOUS TRANSLUMINAL PROCEDURE THE MARKER BAND ON A 2.9F MICRO CATHETER DETACHED WITHIN A UFE CATHETER. THE PHYSICIAN SUCCESSFULLY EXTERNALIZED THE MARKER BAND TOGETHER WITH THE UFE CATHETER RESULTING IN NO FOREIGN BODY INTRODUCTION WITHIN THE PATIENT. ANOTHER CATHETER WAS PREPPED AND SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12665599 ↗
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- RebarTM 105-5081-153Micro Therapeutics, Inc. · Catheter, continuous flush2 deaths102 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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